Quality analysis of the clinical laboratory literature and its effectiveness on clinical quality improvement: a systematic review

Abstract

Quality improvement in clinical laboratories is crucial to ensure accurate and reliable test results. With increasing awareness of the potential adverse effects of errors in laboratory practice on patient outcomes, the need for continual improvement of laboratory services cannot be overemphasized. A literature search was conducted on PubMed and a web of science core collection between October and February 2021 to evaluate the scientific literature quality of clinical laboratory quality improvement; only peer-reviewed articles written in English that met quality improvement criteria were included. A structured template was used to extract data, and the papers were rated on a scale of 0–16 using the Quality Improvement Minimum Quality Criteria Set (QI-MQCS). Out of 776 studies, 726 were evaluated for clinical laboratory literature quality analysis. Studies were analyzed according to the quality improvement and control methods and interventions, such as training, education, task force, and observation. Results showed that the average score of QI-MQCS for quality improvement papers from 1981–2000 was 2.5, while from 2001–2020, it was 6.8, indicating continuous high-quality improvement in the clinical laboratory sector. However, there is still room to establish a proper system to judge the quality of clinical laboratory literature and improve accreditation programs within the sector.

Introduction

The robustness of the healthcare system relies upon the clinical laboratory because all the clinical decisions taken on patients by physicians mainly depend upon the clinical lab reports.^(1,2) About 70–75% of medical diagnoses are obtained via clinical laboratory reports, making laboratory service quality directly impact healthcare quality.^(3,4) Laboratory findings should be precise as possible, also at the same instance; all laboratory operations must be reliable with timely reporting resulting in a beneficial clinical setting.⁽⁵⁾ Negligence during laboratory operations, including processing, assessing, and reporting, can cause severe consequences, including complications, lack of adequate treatment, and delay in correct and timely diagnosis, leading to unnecessary treatment and diagnostic testing.^(6–8) A clinical laboratory is a complex set of cultures that include several activity steps, and many people make it unique and saucerful. The comprehensive set of these complex operations occurring during a testing process is called the path of the workflow.⁽⁹⁾ The workflow path in a clinical laboratory initializes with the patient and finishes with reporting and comprehending the results. In any clinical lab setting, it is presumed that mistakes will be made in this process due to the high volume of samples, the limited number of staff, and the different steps implicated in the testing process.^(10,11) Errors at any stage of the total testing process (TTP) can result in inaccurate laboratory outcomes. To guarantee the quality of the results, a reliable method for determining errors within the TTP is required.⁽¹²⁾

Significance of quality in the medical laboratory

The term “quality” in the healthcare context has been properly defined by the Institute of Medicine (IOM).⁽¹³⁾ It defines “quality of care as the extent to which health services for individuals and populations increase the probability of desired health outcomes and conform with current professional knowledge.” More recently, quality has been characterized as “doing the right things for the right people, at the right time and doing them right the first time.” In recent years, quality may entail different domains; there appears to be a consensus emerging that quality involves safety, effectiveness, appropriateness, responsiveness or patient-centered care, equity or access, and efficiency.

Importance of standardization

In the context of laboratory medicine, high-quality diagnostic testing (such as for patient safety) is often achieved through the application of standardized processes. Standardization helps to guarantee the accuracy and reproducibility of test outcomes and their appropriate application to the correct patient and also helps to ensure that the results are accurate. The accreditation agencies guarantee crucial points for standardization in laboratory medicine. There are several authorized CLIA accreditation agencies like the College of American Pathologists (CAP), Joint Commission (JCIA), Accreditation Commission for Health Care, Inc (ACHC), and American Association for Laboratory Accreditation, accreditation, which significantly influences quality improvement (QI) in medical laboratory. However, the international organization of standardization ISO is a non-governmental organization that offers a general framework for all procedural sections up to reporting results. Over the years, the establishment and maturity of each agency have brought significant improvement in the medical laboratory sector. The most crucial accreditation is ISO 15189 among all others because ISO 15189 fixates more on laboratory management systems and processes, e.g., The ISO 15189 standard includes requirements linked to the entire testing process, including pre-examination (i.e., pre-analytics), examination (i.e., analytics), and post-examination (i.e., post-analytics). These requirements include developing and implementing standard operating procedures, validation processes, staff training, internal and external quality control (EQC) measures, laboratory setup, and other aspects. In contrast, the other CLIA-approved laboratory accreditation program concentrates more on technical procedures implicated in testing, e.g., policy statement, certification standards, archive standards, and adequate laboratory testing.

The originality of this study

Several systematic analyses have been published on the quality and management of clinical laboratories, but none focus particularly on the overall QI of medical laboratories (Supplemental Table 1*). This leaves a dent in our understanding of QI in clinical laboratory settings.^(14,15) Regardless of the number of QIs in a medical laboratory context, the high-quality collective QI systematic review is insufficient, which limits our understating of this field and requires further advancement of QI reporting in the clinical laboratory.

Purpose of the study

This study sought to comprehensively review and evaluate published literature on QI in clinical laboratories. The goal was to provide researchers and professionals with a thorough overview of the present knowledge on quality control (QC) and improvement in medical laboratories. Furthermore, the study sought to determine areas for potential future research and developments in the field of QI in this setting.

Materials and Methods

Study design

A systematic review is a technique for objectively summarizing prior research through a systematic and replicable process.⁽¹⁶⁾ This review followed a three-stage design suggested by Tranfield et al. 2003.^(16,17) During the planning stage, the choice of databases and keywords and the inclusion and exclusion criteria for selecting contextual articles were identified. The preferred reporting items for systematic reviews and Meta-analyses flow chart (Preferred Reporting Items for Systematic Reviews and Meta-Analyzes) was employed to illustrate selecting articles for inclusion in the final sample.

Data source

To guarantee comprehensive coverage of the literature, multiple databases were applied in the bibliometric analysis.^(18,19) In this research, the Web of Science (WOS) core collection and PubMed were chosen for their significance to management and medical research. Three keywords were used to determine relevant articles: “quality control” in any of its forms, terms linked to quality processes such as “quality systems,” “quality improvement,” or “quality management,” and “clinical laboratory” to narrow the focus to the healthcare sector using different databases and these keywords helped to guarantee a comprehensive search of the literature on QC and improvement in clinical laboratories.⁽²⁰⁾

Study selection

The present analysis specializes in clinical laboratory QC and improvement research published between 1981 and 2021. To be added, the publication must be a research article and be written in English, with at least a title and summary available. Conference proceedings, letters, notes, reviews, editorials, summaries, and other types of publications were removed from the analysis.

Data processing

Before undertaking the study, we standardized the data to enhance the conformity of the results. We standardized the spelling of the author’s names and the formatting of journal affiliations and other data. We also revised to ensure that citations for each article were not counted multiple times when using both databases. Two authors worked independently to mitigate the risk of errors. Only articles that both reviewers agreed upon were included in the review, as displayed in Fig. 1.

Fig. 1.

PRISMA (preferred reporting items for systematic reviews and meta-analyses)

Quality assessment of literature extracted

The QI Minimum Quality Criteria Set (QI-MQCS) (16) was used to assess this study. The QI-MQCS is employed in the evaluation of QI interventions in healthcare. The QI-MQCS comprises 16 operational and psychometrically dimensions being assessed to present a reliable and accurate assessment of different QI intervention evaluations. Two of the three reviewers in our study individually reviewed the publications. We allocated a score of 1 to each domain with the minimal criterion and a score of 0 to each area that was not satisfied; hence, each article was allocated a score between 0 and 16. The full review committee handled any score disagreements until a consensus was agreed upon. Although the QI-MQCS does not have a set threshold at which the quality of the articles is determined acceptable, “high quality” was defined in this study as a score between 14 and 16.⁽²¹⁾

Results

A total of 776 results were collected from PubMed and WOS bibliographic databases. Of these, 50 were duplicates, and 726 were screened based on their titles and abstracts. After an additional assessment, 224 of the remaining articles were deemed eligible for the QI study, and 53 met the inclusion criteria, as depicted in Fig. 1. The selected papers were classified into QI (n = 19) and QC (n = 33), as presented in Table 1. Most QI studies were performed in university hospital laboratories (n = 34), while some of the QC studies were conducted in general community hospital laboratories (n = 9). There was a great difference in the types of errors detected in these two categories of examinations. Preanalytical errors (n = 12) were the most prevalent in the QI studies. In contrast, analytical errors (n = 28) were the most prevalent error in QC studies.

Table 1.

Characteristics of selected papers

		QI	QC
Number of papers		19	33
Institution type	Hospital	6	3
	University hospital	10	24
	Research center	2	0
	University research center	0	1
	Company laboratory	0	2
	Routine clinical laboratories	1	3
Laboratory type	Tertiary care hospital laboratory	1	0
	University hospital laboratory	10	24
	Hospital clinical laboratory	5	3
	Research laboratory	2	0
	Routine clinical laboratory	1	2
	Public and private laboratories	0	1
	University research laboratory	0	1
	Company laboratory	0	2
Focused error type	Preanalytical	12	4
	Analytical	7	28
	Postanalytical	0	1

QI in the clinical laboratory focuses on preserving quality standards. The 19 extracted papers on QI were classified based on their themes, goals, methods, and interventions. The major theme among these papers was the improvement of clinical quality standards lab practice and training in the laboratory (n = 8), followed by the improvement of problems in the reception area (n = 5), the improvement of TTP (n = 4), the management of preanalytical errors (n = 4), and the evaluation and evolution of quality indicators (n = 2). Accreditation (n = 6) was the most prevalent method employed in these QI approaches. In contrast, training and education (n = 17) were the most common interventions employed to achieve these goals, as highlighted in Table 2.

Table 2.

Characteristics of quality improvement papers

	Number of papers	19
Theme	Clinical quality standard lab practice and training	8
	Improving the reception area problem	5
	Improvement of TTP	4
	Management of preanalytical errors	4
	Utilization and evolution of quality indicator	2
	Lab workspace initiative	1
	Financial and work volume problems	1
	Ratification of errors	1
Aim	Quality indicators utilization evaluation and evolution	2
	reduction of preanalytical errors	2
	Reduce TAT	1
	Utilization of GCLP guidelines	1
	cost reduction approach	1
	work and workspace improvement techniques	1
	Errors evaluation in terms of sigma metrics	1
	Assessing the level of physician satisfaction with clinical lab reports	1
	Reliability of quality control standards	1
	The method validation process for the new lab setup	1
	Intra and inter-laboratory reproducibility of an ELISA to facilitate Lyme disease diagnosis	1
Methods	Accreditation	6
	Six Sigma/PDSA/DMAIC	10
	QI standards and TQM	3
Intervention	Training/Education	17
	Task force	4
	Observation	1
	Reducing waste	1

PDSA, plan, do, study, act; DMAIC, define, measure, analyze, improve, control; TQM, total quality management.

The retrieved papers were classified based on their objectives, goals, and methods to examine the QC characteristics in the clinical laboratory. The core QC analytical processes in these papers included performance evaluation (n = 10), QC assessment (n = 7), improvement of laboratory practices (n = 3), improvement of quality through the use of the sigma metric (n = 8), and the QC criteria for susceptibility testing (n = 7). These processes highlighted the objectives of QC standards in the clinical laboratory. They were implemented using various methods, including accreditation (n = 22), six sigma (n = 12), QC practices (n = 4), statistical approaches (n = 4), external quality assessment (EQA) (n = 2), and EQC (n = 1), as expressed in Table 3.

Table 3.

Characteristics of quality control papers

	Number of papers	33
Objective	Performance evaluation	10
	Quality control assessment	7
	Laboratory practice improvement	3
	Analytical quality assessment	2
	Execution of training and QC program	1
	Design and implementation of IQC	1
	Evaluated the reliability of serological point-of-care	1
	Evaluation of QC practice	1
	Implementation of QC method	1
	Examines the effects of blood-collection tube additives	1
	QC evaluation of ESR	1
	Periodic analysis of quality control	1
	Standard statistical approach	1
	Identification of biomarker for preanalytical QC	1
	Evaluate the validity of blood lead analysis	1
Aim	Quality improvement through sigma metric	8
	QC criteria of susceptibility testing	7
	Examination of training and QC programs	2
	QC specimens Evaluation	2
	Siemens Dimensions Rxl execution	1
	Calculation of CV and bias	1
	Establishment of IQC based on sigma metric	1
	Validation of Z score indicator	1
	IQC system specification	1
	Evaluate POC tests for EBV	1
	Execution of QC method	1
	CUSUM-Logistic Regression for rapid detection of error	1
	Quality control of Median monitoring	1
	Identification of unsatisfactory scores in the CAP PT surveys	1
	Suggestions Potential biomarker for blood sample quality	1
	Estimation of QC material	1
	Assessment of total testing errors	1
	Identification of disparities	1
Method	Accreditation	22
	Six Sigma	12
	QC Practice	4
	Statistical approach	4
	EQA	2
	EQC/IQC/GQC	3

EQA, external quality assessment; EQC, external quality control; POC, point of care; EBV, Epstein-Barr virus; IQC, internal quality control.

Discussion

In this systematic review, we evaluated the present state of QI interventions, the frequency of errors in clinical laboratories, and the prevalence of issues in QI reporting by systematically examining QI articles in clinical laboratory contexts. As the number of QI publications in healthcare has elevated, so is the number of QI publications in clinical laboratories.⁽²²⁾ Laboratory errors can occur at any stage of the TTP and can promote increased healthcare costs, decreased patient satisfaction, delayed diagnosis, misdiagnosis, and adverse risks to patient health.⁽²³⁾ Despite the increasing automation of laboratory diagnostics, our research discovered that laboratories remain a source of errors that can influence patient care decisions.

Distribution of errors among QI and QC papers

Overall, errors in the preanalytical and postanalytical phases are more prevalent, accounting for most errors.⁽²⁴⁾ Errors within the analytical stage are generally fewer.^(25,26) Our findings indicate that the frequency of errors within the analytical phase has declined in recent years. We categorized the papers into QI and QC to identify the prevalence of errors in each setting. Our findings revealed that preanalytical errors were most predominant in QI papers, comprising 12 out of 19 papers.

In contrast, analytical errors were mostly observed in QC papers, comprising 28 out of 33 papers, as presented in Table 1. This disparity may be due to the focus of the papers in each category. QI papers often address training, education on safety teams, and other interventions that involve direct human interaction, such as phlebotomy, which may elucidate the higher prevalence of preanalytical errors in these papers. However, QC papers often assess methods or processes for improvement, such as six sigma, accreditation, QC practices, statistical approaches, and other related methods, which involve more analysis in the context.

GCLP is a potential source for QI

To prevent errors, the clinical laboratory must be accurate and precise in its testing. A quality assurance system based on GCLP guidelines can help with this, but it necessitates the commitment of both management and technical staff. A study executed by Horace Gumba et al.⁽²⁷⁾ has revealed that improving the workflow, increasing patient satisfaction, evaluating performance, and improving the test-treatment process can all contribute to QI in the clinical laboratory. Implementing GCLP guidelines also requires effective management, a solid foundation of best practices and a focus on quality culture, and training and education. Another study by Horace Gumba et al. 2018⁽²⁸⁾ indicated that on-site training and education have been found to enhance the implementation of quality management systems considerably. Our previously reported data linked to QI supplement these ideas and propose that writing standard operating procedures, improving documentation practices, implementing GCLP guidelines, conducting improvement projects, and providing training on quality indicators can all be efficient interventions for improving the quality in the clinical laboratory, as expressed in Table 2.

Performance evaluation

Performance evaluation in clinical laboratories is crucial for guaranteeing test results’ accuracy, precision, and reproducibility. This is typically accomplished through QC materials. These materials, which have prominent values, are used to validate the performance of the laboratory’s test systems. QC materials can be classified into internal and external types. Internal quality control (IQC) materials are used for consistent monitoring of the laboratory’s test systems, while EQC materials are used for comparison to those of other laboratories. A study was carried out by Loh et al.,⁽²⁹⁾ analyzed several methods used to assess clinical laboratories’ performance, including QC materials and inter-laboratory comparisons. The study highlighted the importance of constant improvement in the QC of clinical laboratories. Our QC paper intentionally highlights this concept in Table 3.

Importance of accreditation in clinical laboratory

Accreditation of clinical laboratories is essential for promoting the quality of clinical laboratory practices. Our findings in Table 3 highlight the significance of accreditation in clinical laboratories, which conforms with the findings of research by Alkhenizan et al.⁽³⁰⁾ One of the main restrictions to implementing accreditation programs is the skepticism of healthcare professionals, particularly physicians, concerning the impact of accreditation on the quality of healthcare services.^(31,32) In healthcare, QI activities are often promoted as part of a total quality management (TQM) strategy, including Kaizen/QI activities in nursing care, medical quality, logistics, administrative work, and patient services. In clinical laboratories, however, the influencing force behind the QI is often linked to accreditation, as it presents formal recognition and certification from a regulatory body that the laboratory is competent and operates effectively.⁽³³⁾

Influence of accreditation in QI and QC studies

To assess the trend of QI in clinical laboratories, we analyzed papers from 1981 to 2021 and made some intriguing findings. There was relatively minimal research on QI or control from the 1980s to 2000s, possibly due to insufficient quality infrastructure, barriers to globalization, and limited access to modern knowledge. Data categorization revealed that QI and QC trends increased considerably after 2000, suggesting a significant improvement in the laboratory sector. Several possible explanations abound for this trend, including increased awareness of the importance of quality healthcare and developing quality management systems. The most substantial factor is the establishment of accreditation agencies such as ISO 15189 and CAP. CAP and ISO 15189 have greatly impacted the clinical laboratory sector through several initiatives and guidelines.⁽³⁴⁾ CAP has had multiple changes from 1994 to 2020, including implementing training and unannounced inspection programs for pathology laboratories, establishing a multiyear initiative to promote the pathology specialty, and introducing CAP 15189 as a voluntary program. ISO 15189 was first published in 2003, offering information on the medical laboratory sector and outlining guidelines for sample procedures, results interpretation, reasonable turnaround times, patient sample collection, and the role of the laboratory in training and educating healthcare staff. It was revised in 2007 to conform with ISO/IEC 17205. A third edition was published in 2012, as depicted in Table 4, which revised the prior layout and added a section on laboratory information management.⁽³⁵⁾ The effects of these changes on QI in clinical laboratories can be seen in our results in Fig. 2 from 2000 onwards, indicating a clear QI trend in medical laboratories.

Table 4.

Introduction of accreditation agencies for the improvement of clinical laboratory

Accreditation agencies	Time frame	Introduction of quality techniques
College of American Pathologists	1946–1996	Certification of hemoglobin standards.
		The professional component in the laboratory.
		Laboratory management index program.
		Cytology policy statement.
		The legal status of pathology.
		Surgical pathology policy.
	1997–2000	Implementation and further advancement of advocating improvement.
	2001–2005	Unannounced inspection programs.
		Several trainings.
	2007–2009	CAP 15189 is a voluntary and non-regulated accreditation to ISO 15189.
		Multiyear initiative.
	2011–2020	Biorepository accreditation program.
		Pathologist quality registry.
		SARS-CoV-2PT.
ISO 15189	First published in 2003	Role of the laboratory in the training and education of health staff.
		Turnaround times.
	Revised in 2007	To align more closely with ISO/IEC 17205.
	Third edition in 2012	Revised the previously published layout and added a new section on laboratory information management.
Joint Commission	2010	Evidence bases lab standards.
		Address the patient safety and quality.
		Survey methodology.

Fig. 2.

Number of QI and QC papers per 5 years from 1981–2020. QC papers were the most published from 2001, indicating the gradual change of quality in clinical laboratory settings.

QI-MQCS as a psychometrically tool for quality publication

To determine the QI of clinical laboratory literature, we used the 16 domains of QI-MQCS.⁽²¹⁾ Each paper was evaluated on these domains and scored on a scale of 0 to 16, with a score of 1 given if at least one reason was outlined. The QI papers generally followed the most domains. These papers were then classified by year of publication, and the average QI-MQCS score was determined. A substantial difference in QI-MQCS scores was detected in articles published between 2000 and 2020, as depicted in Fig. 3. This disparity may be due to the implementation of laboratory QI standards and the accreditation of clinical laboratory facilities, which have been previously outlined.

Fig. 3.

This figure illustrates the scoring pattern of QI-MQCS concerning years of publication. The average score of QI-MQCS from 1981–2000 is 2.5, whereas, from 2001–2020, it is 6.8, which reveals the high quality of continuous enhancement in the clinical laboratory sector.

Limitations and strengths

One of the strengths of this analysis is its thorough analysis of all QI-related clinical laboratory papers. The clinical laboratory field is extensive and includes various subfields, but to our knowledge, only 12 reviews have previously addressed QI in the clinical laboratory. This research is the first to thoroughly evaluate all QI-related clinical laboratory papers in one review. There are some limitations to this research. Firstly, the lack of reporting or evaluation of clinical laboratory studies using QI-MQCS limits our comprehension of the QI process. Second, we assessed and scored all papers based on the 16 domains of QI-MQCS, even though some domains may not have been significant to medical laboratories (Supplemental Table 2*). For example, spread (7%), sustainability (3%), penetration (3%), adherence/fidelity (7%), organizational readiness (11%), and intervention description (11%). This is because clinical laboratories do not typically entail delivering interventions or implementing evidence-based interventions in practice and do not usually require the analysis of performance measurements or process systems or developing connections between people.

The major function of the clinical laboratory is to offer diagnostic support to physicians, which can aid in the treatment process and contribute to further progress. However, the QI-MQCS was developed to help stakeholders determine high-quality studies in their field. QI techniques are diverse and distinct from clinical interventions, and the QI-MQCS is a psychometrically tested tool for evaluating the QI-specific characteristics of QI publications. This analysis has possible bias as it did not include other significant databases like Embase and EBSCOhost and only included articles in English.

Conclusion

This study investigated the trend and scope of QI and QC papers in clinical laboratory practice. Our findings revealed that the trend of QI and QC increased markedly after 2000, possibly due to the implementation of laboratory QI standards and the accreditation of clinical laboratory facilities. Our study emphasizes the importance of compliance with good clinical laboratory practice standards and the potential for collaboration between accredited and non-accredited organizations to enhance the quality management system and influence consistent improvement in the clinical laboratory sector.

Author Contributions

This research paper is the culmination of a joint effort between the author, the co-author YI, and the supervisor EN-Y. The study was conceptualized and designed through collaborative discussions between the author and the supervisor. The data collection process was a collaborative effort with significant contributions from YI, who provided valuable data visualization and analysis guidance. The supervisor was crucial in developing and refining the research framework, offering valuable insights that improved study conceptualization. The co-authors reviewed and revised the manuscript and provided critical feedback on presenting findings, including figures and tables.

Abbreviations

DMAIC

define, measure, analyze, improve, control

EQA

external quality assessment

EQC

external quality control

IQC

internal quality control

PDSA

plan, do, study, act

QI

quality improvement

QC

quality control

QI-MQCS

quality improvement Minimum Quality Criteria Set

TQM

total quality management

Conflict of Interest

No potential conflicts of interest were disclosed.